Driver: The rising number of clinical trials and the availability of advanced CTMS solutions

The life science industry is annually witnessing a global increase in the number of clinical trials. The growth in the number of clinical trials can be attributed to factors such as the high prevalence of chronic diseases, the expiry of blockbuster drugs, the availability of government funds for clinical trials, and fierce competition in the pharmaceutical industry.

In recent years, leading players have launched many CTMS solutions in the market that boast superior performance than their traditional counterparts. These products are cost-effective, easy to use, provide effective patient safety and regulatory compliance, and enhance the financial management capabilities of users. They enable organizations to implement a full-featured CTMS without the complex configuration and heavy capital investment associated with traditional solutions.

Expected Revenue Gains:

The clinical trial management system market is projected to reach USD 1,590 million by 2025, at a CAGR of 14.7 % during the forecast period.

Recent Developments in the Global Clinical Trial Management System Market:

# In June 2019, Parexel International Corporation (US) launched an enhanced integrated outsourcing delivery model for functional service provider (FSP) services at the DIA 2019 Global Annual Meeting in San Diego, US.

# In May 2019, Bio-optronics (US) launched three products to the CCTrialSuite basket application—CCeSource, CCeReg & CCeConsent.

# In June 2018, Bioclinica (US) launched eClinical Solution namely the SMART Technology Suite.

Restraint: Budget Constraints

Small and mid-sized customer facilities often face financial constraints for clinical trials due to limited private funding, rigorous regulatory mandates, and financial outlook. This also includes ineffective site selection, poor study design & trial execution, safety issues, and dropouts due to practical or financial issues. Furthermore, the time and capital required to complete a trial increase at each phase.

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The total cost of a Phase III failure includes the cost of all previous phases, plus the time that could have been used to trial a different drug. Each failed trial contributes to the rising costs of biopharma R&D. Although R&D spending in the life science industry is rising, start-ups and SMEs still face budget constraints, which affect their decision to purchase CTMS solutions. Due to uncertainties in product approvals, undue delays in product approvals, and long gestation periods, private investors usually prefer established firms to invest in rather than start-ups and SMEs.

Opportunity: Investment in effective digital infrastructure and agility in technological adoption

The need to comply with stringent regulations has been crucial to expediting the adoption of new technology in research. Although the supply of technology has been increasing and the regulation of innovative methods is easing, pharmaceutical companies have been slow to use emerging technologies due to the uncertainty prevailing around this space and a highly fragmented supply market. Lately, pharma companies have increased expenditure on AI and big data analytics, given their transformative supremacy over the R&D process and cost savings.

Fear of rivalry in the market and the need for business transformation and agility are key forces driving huge investments in R&D technologies. Hence, pharma companies must recognize outward innovation through supplier benchmarking in each of these categories and be involved in early engagement through co-development to stay competitive.

Geographical Growth Scenario:

The clinical trial management system market covers five key geographies—North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. In 2019, Asia Pacific region is expected to offer significant opportunities for the growth of the clinical trial management system market.

The major factors driving the growth of the Asia Pacific market include increasing government funding to support clinical trials, the presence of less stringent regulatory guidelines as compared to developed nations, a large patient base, faster rate of patient recruitment for clinical trials than mature nations, low operating costs for conducting clinical trials, a shortage of trial volunteers in Europe and North America, and the growing number of pharmaceutical companies and CROs in the region.

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Global Leading Companies:

Oracle Corporation (US), Medidata Solutions (US), Parexel International (US), Bioclinica (US), and IBM (US), Bio-Optronics (US), Datatrak (US), Veeva Systems (US), DSG (US), MasterControl (US), ERT (US), Advarra Technology Solutions (US), MedNet Solutions (US), ArisGlobal (US), DZS Clinical Services (US), Crucial Data Solutions (US), Ennov (France), DataStat (US), and RealTime Software Solutions LLC (US) among others are some of the major players operating in the global clinical trial management system market, among others.